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510(k) Data Aggregation

    K Number
    K031818
    Device Name
    FACILAI VARIOUS MODELS OF SINGLE USE ACUPUNCTURE NEEDLE
    Date Cleared
    2003-12-03

    (174 days)

    Product Code
    Regulation Number
    880.5580
    Why did this record match?
    Applicant Name (Manufacturer) :

    FACILAI ENTERPRISES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
    Device Description
    FACILAI VARIOUS MODELS OF SINGLE USE ACUPUNCTURE NEEDLE
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